6.3.4 FDA GOOD MANUFACTURING PRACTICES (GMP) FOR MEDICAL DEVICES

Abstract

AbstractThe objective of the presentation is to discuss the Food and Drug Administration change to the Good Manufacturing Practices (GMP) rules. The proposed changes have a direct relationship to and integration of System Engineering processes and methods. As systems become more complex, procedures must be followed that organize and discipline the structure of development. Design controls must be enacted that increase the safety and effectiveness of medical devices. The FDA is in the process of changing these rules so processes must be defined and followed. It also puts the FDA development and production requirements more in line with ISO 9000. As stated by FDA, ISO 9000 has been incorporated into the new rules, but the new rules go much further.As evidenced by the following, the processes that are being enacted by FDA are not new in structure or content, but emphasize the need for the engineering community to define the development and design processes and follow them. The objective of the presentation is to educate the system engineering community on the regulatory constraints that are being enacted by another government agency, the Food and Drug Administration. It is intended that the participant of the presentation will come away with an understanding that the FDA is enacting rules that directly apply to the system engineering process and disciplines associated with system design and development.